Flat Lay Composition With Medical Items On Gray Background
INDUSTRY SOLUTIONS: MEDICAL DEVICES AND DIAGNOSTICS

Tomorrow’s medical devices require flexible operations solutions today.

For medical device manufacturers, compliance is the first among many challenges.

The logistics involved in coordinating product development and manufacturing while meeting compliance requirements are complex. Staying on schedule requires end-to-end supply chain visibility, ensuring both the timely manufacture of devices and traceability in the event of defects. Paper-based guidance and documentation systems lead to poor visibility, siloed data, and manual work — all driving up to the cost of goods sold (COGS) and quality while delaying the release of products for shipment.

Medical Device Factory And Production Indoor

Error-prone paper-based processes

Quality and compliance are burdensome

High levels of non-value-added work

Lack of visibility due to siloed data

Tulip’s no-code platform provides a full, self-auditing eDHR solution.

Reduce the cost of quality while making compliance seamless by building Digital Logbook and Electronic Device History Record (eDHR) apps with Tulip. Ensure products are made to spec and are right the first time, every time by guiding workflows, bringing quality in-line, and enforcing compliance.

Turn your SOPs into interactive, IoT-connected apps.

Digital work instructions apps help enforce standard operating procedures (SOPs) and enforce quality in-line. Ensure staff is trained, equipment is cleaned and calibrated correctly, processes are followed, and products are made to spec. Accelerate New Product Introduction (NPI) with work instructions.

Learn more about work instructions with Tulip >

Minimize the burden of compliance-driven activities on staff.

Streamline documentation around activities, such as equipment use, line clearances, and changeovers. Ensure data integrity and traceability with electronic signatures, audit logs, and automatic data collection.

Track devices, assemblies, and components, and materials through the plant and for recalls.

Ensure 100% traceability with audit logs and a digital approval process. Automatically collect information for work order tracking, including for custom devices. Reduce the headache of recalls by quickly identifying affected devices and batches.

Check out Tulip Library Apps >

Enable Review by Exception for faster predictable release of products from manufacturing to customers.

Release and ship products faster by streamlining documentation and eliminate errors and the time wasted fixing them. Move faster with a self-auditing eDHR that helps you identify issues in real-time.

Learn more about GxP and Compliance >

Gain real-time visibility into quality and production information.

Easily analyze process data for root cause analysis and optimization. Connect to ERP Databases for real-time inventory information and recording changes.

Learn about Tulip Analytics >

FDA 21 CFR Part 11 Compliant

FDA GMP

Bureau of Industry and Security EAR Compliant

EAR

GDPR Compliant

GDPR

ITAR Compliant

ITAR

EU GMP compliant

EU GMP

Case Studies

  • Dentsply Case Study Quote overlaid on dental implant manufacturing image

    IoT-connected apps helped Dentsply reduce errors and increase traceability.

    Dentsply Sirona created apps to guide operators through their complex kitting process, allowing them to error-proof the activity while cutting training times by 75%. Dentsply furthered improved their workflow apps by leveraging pick-to-light and creating production dashboards for identifying improvement areas.

    READ THE CASE STUDY

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